• April 4. Tremelimumab + Durvalumab – NSCLC EGFR/ALK. The European Commission has authorised the use of tremelimumab (anti-CTLA-4 antibody) in combination with durvalumab (anti-PD-L1 antibody) and platinum-based chemotherapy for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations
  • April 20. Ipilimumab +Nivolumab – OSCC PD-L1. The European Commission has extended the indication of the immunotherapy combination to include first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PDL1 expression >1%.
  • April 21. Niraparib and abiraterone acetate – mCRPC BRCA 1/2. The European Commission has granted marketing authorisation to dual-action tablet (DAT) niraparib and abiraterone acetate plus prednisone or prednisolone, to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic).
  • May 4. Ivosidenib – AML/CCA IDH1. The IDH1 inhibitor has received marketing approval from the European Commission for two therapeutic indications.  Ivosidenib in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy. Ivosidenib monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
  • May 17. Cemiplimab – NSCLC EGFR/ALK/ROS1. The European Commission has authorised the extension of therapeutic indication to include the anti-PD-1 antibody in combination with platinum?based chemotherapy for the first-line treatment of adult patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for definitive chemoradiation or metastatic NSCLC with no EGFR, ALK or ROS1 aberrations.

CHMP

  • April 26. Futibatinib – CCA FGFR2. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the irreversible kinase inhibitor of FGFR 1, 2, 3 and 4, intended for the second-line treatment of locally advanced or metastatic cholangiocarcinoma (CCA) characterized by fusion or rearrangements of fibroblast growth factor receptor (FGFR2).
  • May 25. Nivolumab – NSCLC PD-L1. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for the anti-PD-1 antibody: neoadjuvant treatment of NSCLC. Nivolumab, in combination with platinum-based chemotherapy, is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression >1%.

FDA

  • May 31. Olaparib – mCRPC BRCA. The Food and Drug Administration approved the PARP inhibitor with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
  • April 17. Botensilimab + Balstilimab – CRC MSI. The FDA has granted a fast track designation to the combination of CTLA-4 inhibitor (botensilimab) and PD-1 inhibitor (balstilimab) for the treatment of patients with non-microsatellite instability-high (non-MSI-H)/deficient mismatch repair (non-dMMR) metastatic colorectal cancer (CRC) who have no active liver involvement.
  • May 2. ERAS-801 – GBM EGFR. The Food and Drug Administration has granted a fast track designation to the EGFR inhibitor with high CNS penetration for the treatment of adult patients with glioblastoma (GBM) harbouring EGFR gene alterations.
  • May 30. Repotrectinib – NSCLC ROS1. The FDA has granted priority review to the ROS1/TRK/ALK Inhibitor for the treatment of patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC).